510(k) · Cleared
ClearedImmusure
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantimetrix Corp. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Oct 29, 1997 after a 15-day review. The FDA summary names its predicate without a number.
- Decided
- Oct 29, 1997
- Review
- 15 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Tri-Point™ Brand Liquimmune® Liquid Assayed Immunoassay Controls Named without a submission number | |
| * | — | Dade® Immunoassay Controls Comprehensive Tri-Level Named without a submission number | |
| * | — | Liquichek™ Immunoassay Plus Control Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Quantimetrix Immusure Immunoassay/TDM Control is to be used as a quality control material to assess the accuracy and precision of laboratory test methods used to measure the serum analytes and therapeutic drugs contained in the control. It is intended to validate the measurement of these analytes and drugs in patient serum samples. Quality Control materials having known component concentrations are an integral part of diagnostic procedures. Daily…
Read the full statement (122 words)
The Quantimetrix Immusure Immunoassay/TDM Control is to be used as a quality control material to assess the accuracy and precision of laboratory test methods used to measure the serum analytes and therapeutic drugs contained in the control. It is intended to validate the measurement of these analytes and drugs in patient serum samples.
Quality Control materials having known component concentrations are an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method. CLIA regulation 493.1202(C)(4) requires labs to perform and document control procedures for each day of testing.
Three levels of control are provided to allow the performance of the analyte test methods to be monitored within the clinically significant range.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973894 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973894: Immusure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973894
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026